NIH DOCUMENTS PROVIDE NEW EVIDENCE U.S. FUNDED GAIN-OF-FUNCTION RESEARCH IN WUHAN

U.S.-funded experiment in China posed biosafety risks but did not cause Covid-19 pandemic, scientists say.

NIH DOCUMENTS contain new evidence that the Wuhan Institute of Virology and the nearby Wuhan University Center for Animal Experiment, along with their collaborator, the U.S.-based nonprofit EcoHealth Alliance, have engaged in what the U.S. government defines as “gain-of-function research of concern,” intentionally making viruses more pathogenic or transmissible in order to study them, despite stipulations from a U.S. funding agency that the money not be used for that purpose.

Grant money for the controversial experiment came from the National Institutes of Health’s National Institute of Allergy and Infectious Diseases, which is headed by Anthony Fauci. The award to EcoHealth Alliance, a research organization which studies the spread of viruses from animals to humans, included subawards to Wuhan Institute of Virology and East China Normal University. The principal investigator on the grant is EcoHealth Alliance President Peter Daszak, who has been a key voice in the search for Covid-19’s origins.

Scientists unanimously told The Intercept that the experiment, which involved infecting genetically engineered mice with “chimeric” hybrid viruses, could not have directly sparked the pandemic. None of the viruses listed in the write-ups of the experiment are related to the virus that causes Covid-19, SARS-CoV-2, closely enough to have evolved into it. Still, several scientists said the new information, which the NIH released after it was sued by The Intercept, points to biosafety concerns, highlighting a general lack of oversight for research on pathogens and raising questions about what other information has not been publicly disclosed.

“As a virologist, I personally think creating chimeras of SARS-related bat coronaviruses that are thought to pose high risk to humans entails unacceptable risks,” said Jesse Bloom, who studies the evolution of viruses at the Fred Hutchinson Cancer Research Center. Severe acute respiratory syndrome, or SARS, is a disease caused, like Covid-19, by an airborne coronavirus.

The experiment also raises questions about assertions from Fauci and NIH Director Francis Collins that NIH-funded projects at the Wuhan Institute of Virology did not involve gain-of-function research. In May, Fauci testified before Congress: “The NIH has not ever and does not now fund gain-of-function research in the Wuhan Institute of Virology.” The documents do not establish whether Fauci was directly aware of the work.

Scientists working under a 2014 NIH grant to the EcoHealth Alliance to study bat coronaviruses combined the genetic material from a “parent” coronavirus known as WIV1 with other viruses. They twice submitted summaries of their work that showed that, when in the lungs of genetically engineered mice, three altered bat coronaviruses at times reproduced far more quickly than the original virus on which they were based. The altered viruses were also somewhat more pathogenic, with one causing the mice to lose significant weight. The researchers reported, “These results demonstrate varying pathogenicity of SARSr-CoVs with different spike proteins in humanized mice.”

But the terms of the grant clearly stipulated that the funding could not be used for gain-of-function experiments. The grant conditions also required the researchers to immediately report potentially dangerous results and stop their experiments pending further NIH review. According to both the EcoHealth Alliance and NIH, the results were reported to the agency, but NIH determined that rules designed to restrict gain-of-function research did not apply.

The Intercept consulted 11 scientists who are virologists or work in adjacent fields and hold a range of views on both the ethics of gain-of-function research and the Covid-19 origins search. Seven said that the work appears to meet NIH’s criteria for gain-of-function research.

One said that the experiment “absolutely does not meet the bar” for gain-of-function research. “You can’t predict that these viruses would be more pathogenic, or even pathogenic at all in people,” said Angela Rasmussen, a virologist with the Vaccine and Infectious Disease Organization at the University of Saskatchewan. “They also did not study transmissibility at all in these experiments,” meaning that the scientists did not look at whether the viruses could spread across a population.

Three experts said that, while they did not have enough knowledge of U.S. policies to comment on whether the research met NIH criteria, the experiment involving humanized mice was unnecessarily risky.

One virologist, Vincent Racaniello, a professor of microbiology and immunology at Columbia University, said while he considered the mouse experiment described in the document to clearly fall into the gain-of-function category, he didn’t see it as problematic. “You can do some kinds of gain-of-function research that then has unforeseen consequences and may be a problem, but that’s not the case here,” said Racaniello.

Robert Kessler, communications manager for EcoHealth Alliance, denied that the work on the humanized mice met the definition of gain-of-function research. Kessler insisted that bat viruses are not potential pandemic pathogens because, he said, “a bat virus is not known to be able to infect humans.” The proposal justified the work on WIV1 by explaining that it is “not a select agent” — referring to a list of closely monitored toxins and biological agents that have the potential to pose a severe threat to public health — and “has not been shown to cause human infections, and has not been shown to be transmissible between humans.”Understanding-Risk-Bat-Coronavirus-Emergence-Grant-Notice528 pages

But the group’s bat coronavirus research was focused on the very threat that bat viruses pose to people. Kessler did acknowledge that, while the original bat coronavirus in the experiment did not spread among humans, the research was designed to gauge how bat coronaviruses could evolve to infect humans.

All but two of the scientists consulted agreed that, whatever title it is given, the newly public experiment raised serious concerns about the safety and oversight of federally funded research. “In my point of view, the debate about the definition of ‘gain-of-function’ has been too much focused on technical aspects,” said Jacques van Helden, a professor of bioinformatics at Aix-Marseille Université. “The real question is whether or not research has the potential to create or facilitate the selection of viruses that might infect humans.” The experiments described in the proposal clearly do have that potential, he said.

NIH spokesperson Elizabeth Deatrick said that the agency had considered the research — and decided not to restrict it under its own rules. “In 2016, NIAID determined that the work was not subject to the Gain-of-Function (GoF) research funding pause and the subsequent HHS P3CO Framework,” Deatrick wrote, referring to criteria put in place in 2017 to guide the agency’s funding decisions about research that involves, or is reasonably anticipated to involve, potential pandemic pathogens.

Republican members of Congress have alleged, without sufficient evidence, that gain-of-function research in Wuhan sparked the coronavirus pandemic. As part of an inquiry into the origins of the pandemic, they have twice grilled Fauci in Congress on his role as NIAID director.

In a heated exchange in July, Republican Sen. Rand Paul accused Fauci of lying when he claimed that NIH did not fund gain-of-function research at the Wuhan Institute of Virology.

Experts now say that the documents support the contention that NIH funded gain-of-function work, though not in the specific instance where Paul alleged it. “There’s no question,” said Racaniello, of Columbia University, who pointed to the decreased weight of the mice infected with the chimeric viruses that was described in the research summaries sent to NIH. “From the weight loss, it’s gain of function. Tony Fauci is wrong saying it’s not.”

But the documents do not prove Paul’s claim that Fauci was lying, as they do not make clear whether Fauci read them. Nor do they in any way support Paul’s allegation that Fauci was “responsible for 4 million people around the world dying of a pandemic” — or that anyone intentionally caused Covid-19. What is clear is that program officers at NIAID, the agency that Fauci oversees, did know about the research.

A paragraph describing the research, as well as two figures illustrating its results, were included in both a 2018 progress report on the bat coronavirus grant and an application for its 2019 renewal. And NIH confirmed that it reviewed them.

“NIH has never approved any research that would make a coronavirus more dangerous to humans,” the agency said in a statement, echoing remarks by Collins, the NIH director, posted to its website in May. “The research we supported in China, where coronaviruses are prevalent, sought to understand the behavior of coronaviruses circulating in bats that have the potential to cause widespread disease.” Similar research funded by NIH had aided in the development of vaccines against the coronavirus, the statement continued.

The White House did not respond to questions about the research.

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